Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, NDC 43598-561-78.

FDA recall notice · announced May 11, 2022 · Dr. Reddy's Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, NDC 43598-561-78.

Reason for recall

Failed Dissolution Specifications

Notes

Distribution: OH
Lot/code information: Lot #: T2000645, Exp 07/2022
Quantity: 252 Blister Packs
Status: Terminated
Products in this recall event:
- Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 085 (D-0853-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.